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U.S. Department of Health and Human Services

Class 2 Device Recall BreathTek

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  Class 2 Device Recall BreathTek see related information
Date Initiated by Firm May 02, 2007
Date Posted October 04, 2007
Recall Status1 Terminated 3 on November 26, 2007
Recall Number Z-0003-2008
Recall Event ID 38430
510(K)Number K014225  
Product Classification in vitro diagnostic software - Product Code MSQ
Product BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
Code Information Version 1.3.5 - January 1, '03
Recalling Firm/
Manufacturer		 Meretek Diagnostics, Inc.
2655 Crescent Drive, Suite C
Lafayette CO 80026
For Additional Information Contact Juli Marki
720-479-6409
Manufacturer Reason
for Recall		 Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.
Quantity in Commerce 92 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSQ and Original Applicant = MERETEK DIAGNOSTICS, INC.
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